Drug trial subjects damaged for life

A couple of months ago (Daily Dose, April 14th), I wrote to you about a March drug trial gone horribly wrong in the UK. I promised you an update on the story if there were any new developments.

But first, to recap a bit…

An American firm called Parexel was running a small trial at a British hospital for TGN1412, an experimental leukemia and arthritis drug developed by German firm Tegenero, AG, and manufactured by yet another company, Boehringer-Ingelheim. Eight young male subjects were enrolled in two groups, a placebo-medicated control group (two people), and the chemical group (six people). Within hours of taking their doses via injection:

* Several test subjects in the chemical group started tearing off their clothes in agony or claiming their heads felt like they were about to explode

* One 28-year old subject's head and neck rapidly swelled to three times the normal size, while others complained of stabbing pains in their backs

* All of the subjects in the chemical group passed out after vomiting and writhing in pain as through stricken with palsy

* All six chemical-group subjects experienced precipitous plunges in their white-cell counts (the blood cells vital to immunity) within hours of the trial.

* All six subjects in the TGN1412 test group experienced multiple organ failure and had to be rushed to the hospital's ICU
All this agony came from what was expected to be a SUB-CLINICAL dose of the drug - 1/500th of what animal studies indicated was tolerable!

Of course, the trial itself fell woefully short of established standards in the areas of medical oversight and due diligence - especially with regard to the administration of experimental drugs. TGN1412 had never been tested on humans before (and may never have been sufficiently tested on animals), and so warranted extra precautions outlined in the Textbook of Pharmaceutical Medicine.

These guidelines were ignored in the trial. I'm sure this is cold comfort to the victims, all of which were hospitalized for weeks (one stayed more than three months) and one of which now faces a mysterious new case of CANCER.

According to Wikipedia and other sources, one of the volunteers in the chemical group for TGN1412 has developed early signs of lymphoid malignancy since the fateful Ides of March trial…

Another article (Sunday Times from July 30th) cites one immunologist who claims the volunteers are all now woefully deficient in T-cells, averaging between one third and one fifth of what normal, healthy men of their age range should have. You don't need to be an immunologist to surmise that this portends major health risks for these poor folks in the future.

The head of the pharmacology program at University College London concurs, estimating that these victims of shoddy oversight and criminally negligent trial design may never have normal lives - and are likely to endure long-term immune-system deficiencies. All of the men involved in the trial's chemical group have been advised that they may face a lifetime of susceptibility to cancer, MS, lupus, arthritis, and all manner of other autoimmune diseases…

And just think about this: This "drug trial of Dr. Moreau" took place in Britain, where the press is extremely powerful in its ability to uncover facts and information. Yet every drug out there went through early-stage, small-scale experimental human trials somewhere.

Makes you wonder what we're NOT hearing about when and where it's happening, doesn't it?